SUPPLY CHAIN ARTICLES
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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
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![GettyImages-1269045566-rna]( "The Expanding Patent Landscape For RNA-Based Therapeutics")
The Expanding Patent Landscape For RNA-Based TherapeuticsThe COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "The mRNA Supply Chain Revolution: Materials, Methods, And Momentum")
The mRNA Supply Chain Revolution: Materials, Methods, And MomentummRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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![comic art style speech-GettyImages-1342084200]( "“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA")
“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNAIt goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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![women gossiping-GettyImages-72131155]( "A \"Hot Take\" on Personalized mRNA Medicines")
A "Hot Take" on Personalized mRNA MedicinesmRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
SUPPLY CHAIN VIDEOS
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
Camp4’s Satya Kuchimanchi highlights where he has seen the most growth in the oligo supply chain over the past few years, as well as which industry trends have been driving these shifts.
Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Cryopreservation GettyImages-172640159]( "Integrate Cryopreservation Into the End-To-End Supply Chain")
Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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![Cell Gene Technology]( "Where Can Novel Non-Viral Polymeric Delivery Agents Take Us?")
Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Supercharge Your Supply Chain: Harness AI To Gain Competitive Advantage")
The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
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![GettyImages-1297146235-dna]( "Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges: Plasmid DNA Manufacturing")
This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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![Merck Building-shmear]( "Biopharma Supply, Reimagined: Regional, Resilient Manufacturing")
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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![Cryoport]( "Why Risk Analysis And Lane Qualification Matter")
Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
